Remibrutinib

Novartis says it has submitted a Rhapsido filing with the FDA for an approval decision in symptomatic dermographism, the most common form of chronic inducible urticaria. Less than half a year after winning an inaugural green light in chronic hives, Novartis’ oral BTK inhibitor Rhapsido is jockeying to expand its urticaria reach into a new indication where it has the potential to become the first targeted therapy. In top-line results issued Wednesday, Novartis revealed that a phase 3 trial of Rhapsido (oral remibrutinib) met its primary endpoint in patients with the three most prevalent types of chronic inducible urticaria (CIndU): symptomatic dermographism, cold urticaria and cholinergic urticaria. Specifically, the company’s BTK inhibitor helped patients achieve “significantly higher complete response rates” compared with placebo after 12 weeks of treatment, Novartis said in a Feb. 18 press release. Details were slim in the company’s announcement, though Novartis emphasized the potential of Rhapsido to meet a major unmet need in the condition—which currently lacks an approved targeted therapy—adding that it has now submitted a filing with the FDA for an approval decision in symptomatic dermographism, the most common form of CIndU. The company further plans to detail the study results at an upcoming medical meeting and says it will share the full dataset with global regulators in the “coming months.”  Novartis’ study, dubbed Remin, enrolled 364 adults with CIndU whose condition could not be managed with H1-antihistamines. Aside from the primary endpoint around complete responses, the trial also assessed Rhapsido's benefits across secondary measures like itch improvement and hive severity, among others. Chronic inducible urticaria is a chronic skin condition estimated to affect around 29 million people worldwide. A form of chronic urticaria, the condition is marked by hives and swelling, which can be triggered by factors like pressure, sunlight, friction, heat, cold or water, Novartis explained. That characteristic sets the condition apart from chronic spontaneous urticaria (CSU)—where Rhapsido is already approved and which has no specific triggers. Given the lack of approved targeted therapies for CIndU, most patients with the condition are forced to cycle through antihistamines despite limited relief from their symptoms, according to Novartis. In symptomatic dermographism specifically—where Novartis is angling for its FDA approval—itchy hives form from shear force on the skin, such as friction or light scratching, manifesting less than five minutes after contact and typically lasting around half an hour. “The positive RemIND trial results across three different types of CIndU underscore the potential of oral remibrutinib to achieve complete symptom relief for people living with CIndU and build on its recent FDA approval in chronic spontaneous urticaria (CSU),” Angelika Jahreis, M.D., Ph.D., Novartis’ global head of immunology development, said in a statement.“Today’s findings reinforce that remibrutinib could be the first targeted therapy to improve spontaneous and inducible forms of chronic urticaria, helping address a major gap in care for people living with these conditions,” she continued.  Novartis is drafting its Rhapsido expansion plans shortly into the drug’s life span, with the medication’s first FDA nod in CSU arriving back in September. In that indication, Rhapsido is approved in patients whose symptoms persist despite H1 antihistamine treatment.CSU is, however, a much more crowded indication, with Novartis’ own Roche-partnered Xolair and Sanofi and Regeneron’s Dupixent already formidable forces in the space. Unlike the typically twice-a-day tablet Rhapsido, both Xolair and Dupixent are injected. Outside the drug’s current urticaria niche, Novartis is also developing remibrutinib in myasthenia gravis and multiple sclerosis, with a phase 3 readout in relapsing MS expected sometime in the second half of 2026.